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LUX-Lung 4: BIBW 2992 (Afatinib) Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

NCT00711594 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-01-15

Study results available
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Summary

The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine the recommended dose for the Phase II step.

The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose determined in the Phase I step.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

BIBW 2992 MA2 40mg/day

Phase I step: Increased dose cohorts from low dose to MTD

DRUG

BIBW 2992 MA2 50mg/day

Phase I step: Increased dose cohorts from low dose to MTD

DRUG

BIBW 2992 MA2 20mg/day

Phase I step: Increased dose cohorts from low dose to MTD

DRUG

BIBW 2992 QD

Phase II step: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs.

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711594 on ClinicalTrials.gov